Enable AccessibilityEnable Accessibility

Interview with Teresa Bitetti, President of Global Oncology Business Unit, on FDA approval of mobocertinib


In September, the U.S. Food and Drug Administration (FDA) approved EXKIVITY™ (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.1 We sat down with Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, to better understand what this approval means for patients living with this cancer and how Takeda is continuing to innovate and invest in research and development.

Q: What is the significance of this approval?

Teresa Bitetti: The approval of EXKIVITY in the U.S. represents remarkable progress for individuals living with NSCLC with EGFR Exon20 insertion mutations, offering the first-ever oral therapy specifically designed to treat this serious form of lung cancer following chemotherapy treatment1. NSCLC is responsible for 85% of new cases of lung cancer each year and patients with EGFR Exon20 insertion+ NSCLC make up approximately 1-2%2,3 of patients with NSCLC. Historically, people living with this disease have faced a unique set of challenges, including difficulty receiving the right diagnosis, and have also lacked targeted treatment options that can improve their response rates.

EXKIVITY’s approval marks an important step forward for patients by offering a new treatment option and the first effective oral therapy. We’re thrilled with the FDA’s decision and are committed to continuing to meet the needs of underserved patient populations by discovering and delivering other transformative medicines.

Q: Currently, this is an underdiagnosed disease. How are you working to address this?

: NSCLC with EGFR Exon20 insertion mutations is a cancer that previously had few effective treatment options. When it comes to detecting EGFR Exon20 insertions, current standard testing, polymerase chain reaction (PCR) testing, detects less than 50% of cases. The FDA simultaneously approved ThermoFisher’s Oncomine Dx Target Test, which uses next-generation sequencing (NGS) to more accurately diagnose patients compared to PCR testing.

We are also educating clinicians about the EGFR Exon20 disease state and best practices for testing to identify patients with these EGFR Exon20 insertion mutations. Robust, accurate and timely testing is crucial to help HCPs make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease.

Q: How does EXKIVITY™ address an unmet need within the patient community?

TB: EXKIVITY is the first and only oral effective therapy designed to target NSCLC with EGFR Exon20 insertion mutations, providing patients who have previously had limited treatment options.

EXKIVITY also provides patients with a therapy that has shown clinically meaningful and durable responses, reinforcing its value for these patients who are in critical need of targeted treatment options.

Q: What future product milestones are expected in the oncology therapeutic area? How do you see oncology as an area of future growth for the business?

TB: The approval of EXKIVITY is one of many successes we expect to deliver in the coming years and underscores our deep commitment to innovation and addressing the needs of patients. Overall, Takeda is positioned to deliver near-term growth through global brand expansions and through Wave 1 and Wave 2 of our pipeline.

Oncology is one of Takeda’s five key business areas. Currently, our oncology business is working on multiple NMEs across our Wave 1 and Wave 2 pipelines that will support Takeda’s growth through FY25 and beyond. Takeda will continue to work to provide solutions to prevent, diagnose and treat cancer through our R&D efforts.

Q: What does the approval of EXKIVITY™ mean for you on a personal level?

TB: Personally, this approval has been a great source of pride and optimism. I am extremely proud of our Global Oncology team at Takeda and the nearly 50,000 employees globally that work each and every day to develop and deliver critical therapies that serve patients worldwide.

Overall, this approval milestone reinforces our widespread commitment to meeting the needs of underserved patient populations within the oncology community. We are grateful to the patients and researchers who made this milestone possible and look forward to continuing conversations with regulatory agencies around the globe to introduce EXKIVITY as a new effective and safe treatment option for patients across the world.


For 240 years, Takeda has focused on bringing better health and a brighter future to people around the world by translating science into life-changing medicines that make a critical difference to patients. The approval of EXKIVITY™ in the United States represents another milestone for Takeda’s pipeline and a positive landmark for our Wave 1 and Wave 2 of innovation. With multiple best-in-class / first-in-class new molecular entities (NMEs) being evaluated across all our core therapeutic areas with the potential for approvals through FY2024, Takeda’s Wave 1 continues to be well poised to generate near-term growth. Looking further ahead, our Wave 2 is set to deliver sustained growth through FY2025 and beyond.

Learn more about our pipeline and how we’re delivering waves of innovation for patients in need.

1This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2American Cancer Society. What is Non-Small Cell Lung Cancer? https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
Riess, Jonathan W. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. https://www.jto.org/article/S1556-0864(18)30770-6/fulltext. Accessed April 7, 2020.



QTc Interval Prolongation and Torsades de Pointes: EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation. Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed.
Cardiac Toxicity: Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.
Diarrhea: Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information
This article contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.